The Effect of Large Versus Small Clog Size on Emergency Response Time

Occupational Injuries Clinical Trial

Official title:

The Effect of Large Versus Small Clog Size on Healthcare Professional Emergency Response Time: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406220
• Other study ID #: 2019-clog
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In many hospitals, clogs, usually white, are provided for healthcare workers. In our hospital, health care professionals from the department of intensive care medicine may be summoned to an emergency situation on a 24/7 basis. Clogs are thought to be of importance for running. Although clogs are available in several sizes, clog size is typically left to the discretion of the individual healthcare worker. Interestingly,

The primary goal of this randomized controlled trial is to assess if wearing large size clogs as compared to small size clogs results in increased running speed.

Participants will be randomized to small versus large clog size using a using randomly permuted blocks stratified by gender. Following randomization, participants will wear the clogs of allocated size and complete a standardized running course.

The primary endpoint is the time taken to complete the course.

The enrolment of 50 subjects would provide 80% power to show a 5-second difference in the response time at an average response time of 30 seconds with a 6 second standard deviation.

The ethical committee judged the study protocol exempt from extensive review.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthcare workers aged 18 years or older.

Exclusion Criteria:

• Inability to run on clogs.

Related Conditions & MeSH terms

• Clothing
• Emergencies
• Occupational Injuries

Intervention

Other:
• Small clog size
Participants will be randomized to run in small clogs
• Large clog size
Participants will be randomized to run in large clogs

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
VU University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete the running course	The time to complete the course will be compared between the two groups using a linear model with the randomized allocation and the stratification variable as covariates.	Follow-up until 60 minutes.
Secondary	Adverse events		Follow-up until 60 minutes.
Secondary	Time to complete the running course for specific subgroups: By gender, job function, level of fitness.		Follow-up until 60 minutes.